Xiang Lei ointment for healing diabetic-related ulcers

Randomized Controlled Trial on the Efficacy and Safety of Xiang Lei Ointment in Diabetic-related Ulcer Management

This will test whether adding Xiang Lei ointment to standard wound care helps people with diabetic ulcers heal faster and with acceptable safety.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking University Third Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06841237 on ClinicalTrials.gov

What this trial studies

This is a randomized, controlled study at Peking University Third Hospital comparing Xiang Lei ointment plus clinical standard treatment versus clinical standard treatment alone for diabetic-related ulcers. Eligible adults with type 1 or type 2 diabetes and a diabetic ulcer in the granulation phase (with HbA1c <10% at enrollment) are randomized to topical Xiang Lei application plus usual wound care or to usual wound care alone. Participants receive regular wound assessments, infection monitoring, and safety labs, with outcomes focused on wound healing, infection control, and adverse events. The trial is motivated by preclinical rationale that modulating macrophage polarization may help transition chronic wounds from a pro-inflammatory to a proliferative phase to promote repair.

Who should consider this trial

Good fit: Adults with type 1 or type 2 diabetes, controlled blood glucose (HbA1c <10%), and a diabetic ulcer in the granulation phase who can give informed consent are ideal candidates.

Not a fit: People with uncontrolled diabetes, active wound bleeding, very low albumin or hemoglobin, or serious uncorrected comorbidities are unlikely to qualify or benefit from this intervention.

Why it matters

Potential benefit: If successful, the ointment could speed healing, lower infection rates, and reduce the need for amputations.

How similar studies have performed: Topical herbal formulations and macrophage-targeting approaches have shown some promise in wound healing, but clinical evidence specifically for Xiang Lei ointment is limited.

Eligibility criteria

Inclusion Criteria:

* a confirmed diagnosis of type 1 or type 2 diabetes mellitus that meets the standard World Health Organization definition, with blood glucose controlled prior to enrolment and a glycated haemoglobin HbA1c level of less than 10%;
* the type of wound is an ulcer;
* the wound etiology is diabetic, mainly abnormalities in blood glucose, resulting in poor or prolonged healing and requiring standard wound therapy;
* the staging of the wound is in the granulation phase;
* voluntary participation in the study and signing of an informed consent form.

Exclusion Criteria:

* acute heart attack, heart failure, hepatitis, shock, expiratory failure and other serious diseases that have not been corrected;
* uncontrolled blood glucose, fasting blood glucose \> 15 mmol/L and glycated haemoglobin \> 12%;
* active bleeding in the wound, which does not allow the implementation of the conventional basic treatment plan;
* serum albumin \< 20 g/L; haemoglobin \< 60 g/L; platelets \< 50 x 109/L;
* a state of disseminated infection that is being or will be treated with antibiotics
* patients with advanced malignant tumours;
* active autoimmune disease;
* previous allergy to topical human granulocyte macrophage stimulating factor gel (Jinfuning);
* inability of the patient to co-operate or mental disorder;
* in the judgement of the investigator, the subject has a clearly irremovable cause of wound healing, is unsuitable for the study or is unable to comply with the requirements of the study.

Where this trial is running

Beijing, Beijing Municipality

• Peking University 3rd Hospital — Beijing, Beijing Municipality, China (Recruiting)

Conditions Diabetic Wound; Wound Infection; Wound Heal